510(k) Report

510(k) · Cleared

Cleared

Healicoll

K040314510(k) TraditionalCleared Aug 12, 2004185-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Encoll Corp. · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Aug 12, 2004 as substantially equivalent to K913023 (Biocore, 1991) and 6 other predicates after a 185-day review. Its family tree reaches back 3 generations to 1988.

Decided
Aug 12, 2004
Review
185 days
Class
Class U
Product code
KGN
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K881854 (1988). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1999: 1 other ancestor1993: 1 other ancestor1991: 3 other ancestors1998: 1 other ancestorK881854 · Sorbsan Topical Wound Dressing · E.G. Dick & Assoc. · 1988K982597 · Fibrcol Plus Collagen Wound Dressing with Alginate · Johnson & Johnson Medical, Inc. · 1998K993948 · Sis Wound Dressing II · Cook Biotech, Inc. · 200019851990199520002005
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors K993948 · Sis Wound Dressing II · Cook Biotech, Inc. · 2000K982597 · Fibrcol Plus Collagen Wound Dressing with Alginate · Johnson & Johnson Medical, Inc. · 1998K881854 · Sorbsan Topical Wound Dressing · E.G. Dick & Assoc. · 19880
  1. Root · 3 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
  2. 2 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
  3. 1 generation backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
  4. This deviceK040314 HealicollEncoll Corp. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K881854Sorbsan Topical Wound DressingE.G. Dick & Assoc.1988—
−2K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc.1998—
−1K993948Sis Wound Dressing IICook Biotech, Inc.2000—
0 (this device)K040314HealicollEncoll Corp.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199130
199310
199810
199910
200110
FIG. 1 — Lineage of K040314, 1988–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KGN device

  1. #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K913023Skintemp
Summary page 1
…previously approved by the agency and allowed for marketing towards the management of wounds. Such Predicatedevices are listed below: SkinTemp® Kollagen Particles, K913023 MedifiI® Kollagen Particles, K910944 Collatek® Powder, K012990 HeliDermTM Collagcn Wound Dressing, K990086 hy…
Biocore1991—
*K910944Medifil
Summary page 1
…owed for marketing towards the management of wounds. Such Predicatedevices are listed below: SkinTemp® Kollagen Particles, K913023 MedifiI® Kollagen Particles, K910944 Collatek® Powder, K012990 HeliDermTM Collagcn Wound Dressing, K990086 hyCurcO Advanced Collagen Wound Care, US5506…
Biocore1991—
*K012990Collatek Powder
Summary page 1
…management of wounds. Such Predicatedevices are listed below: SkinTemp® Kollagen Particles, K913023 MedifiI® Kollagen Particles, K910944 Collatek® Powder, K012990 HeliDermTM Collagcn Wound Dressing, K990086 hyCurcO Advanced Collagen Wound Care, US5506 Fibracol TM Collagen-Algi…
Biocore Medical Technologies, Inc.2001—
*K990086Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram
Summary page 1
…listed below: SkinTemp® Kollagen Particles, K913023 MedifiI® Kollagen Particles, K910944 Collatek® Powder, K012990 HeliDermTM Collagcn Wound Dressing, K990086 hyCurcO Advanced Collagen Wound Care, US5506 Fibracol TM Collagen-Alginate Dressing, K925548 Fibracol PlusTM Colla…
Integra Lifesciences Corp.1999—
*K925548Fibracol Collagen-Alginate Dressing
Summary page 1
…Collatek® Powder, K012990 HeliDermTM Collagcn Wound Dressing, K990086 hyCurcO Advanced Collagen Wound Care, US5506 Fibracol TM Collagen-Alginate Dressing, K925548 Fibracol PlusTM Collagen-Alginate Dressing, K982597 CollagenDressing, K03721 SIS Wound Dressing II, by Cook Biotec…
Johnson & Johnson Medical, Inc.1993—
*K982597Fibrcol Plus Collagen Wound Dressing with Alginate
Summary page 1
…Dressing, K990086 hyCurcO Advanced Collagen Wound Care, US5506 Fibracol TM Collagen-Alginate Dressing, K925548 Fibracol PlusTM Collagen-Alginate Dressing, K982597 CollagenDressing, K03721 SIS Wound Dressing II, by Cook Biotech, K993948 The proposed device is another collagen wound…
Johnson & Johnson Medical, Inc.1998—
Kept off the family treeK003721FDA’s K003721 is Modification to Olympus AU2700 Clinical Chemistry Analyzer
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Olympus America, Inc.20004
*K993948Sis Wound Dressing II
Summary page 1
…M Collagen-Alginate Dressing, K925548 Fibracol PlusTM Collagen-Alginate Dressing, K982597 CollagenDressing, K03721 SIS Wound Dressing II, by Cook Biotech, K993948 The proposed device is another collagen wound dressing that is quite similar with respect to the indications for use, the major…
Cook Biotech, Inc.2000—
*—hyCurcO Advanced Collagen Wound Care
Named without a submission number
—

Also cleared against K913023: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
  • None of the 10 ancestors has a recall.
  • 2 other devices also cite its predicate K913023.

How does its category compare?

All KGN devices

KGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGN

15so far in 2026, the most since 2007

2007: 32008: 62009: 82010: 42011: 72012: 82013: 62014: 52015: 72016: 42017: 72018: 62019: 32020: 52021: 62022: 122023: 92024: 132025: 102026 (partial year): 15
2007high 15 (2026) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGN

162in 2025

2007: 32 days median2008: 87 days median2009: 121 days median2010: 175 days median2011: 228 days median2012: 123 days median2013: 147 days median2014: 188 days median2015: 87 days median2016: 164 days median2017: 136 days median2018: 148 days median2019: 128 days median2020: 279 days median2021: 236 days median2022: 246 days median2023: 194 days median2024: 83 days median2025: 162 days median2026 (partial year): 174 days median
2007high 279 (2020) · low 32 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGN

3in 2018

2017: 12018: 3
2007high 3 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGN

15in 2025

2008: 12009: 22010: 32011: 62012: 42013: 62014: 122015: 92016: 62017: 82018: 152019: 112020: 172021: 142022: 132023: 212024: 152025: 15
2007high 21 (2023) · low 0 (2007)2025

MAUDE reports naming product code KGN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200733200
200868701
2009812102
2010417503
2011722806
2012812304
2013614706
20145188012
201578709
2016416406
2017713618
20186148315
20193128011
20205279017
20216236014
202212246013
20239194021
20241383015
202510162015
2026151740—

What is it indicated for?

The Healicoll Topical Collagen Wound Dressing is intended for the topical wound management that includes:

* Partial and full-thickness wounds.

* Pressure ulcers.

* Venous ulcers.

* Chronic vascular ulcers.

* Diabetic ulcers.

* Trauma wounds (abrasions, lacerations, second-degree burns, skin tears),

* Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

Indications for use as stated in the FDA summary.

Also cleared against K913023

2 other devices cite the same predicate.

  • K122325Skintemp IIHuman Biosciences, Inc. · 2012
  • K993948Sis Wound Dressing IICook Biotech, Inc. · 2000

Recent decisions in KGN

The KGN category page

  • K260920Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc…Berkeley Advanced Biomaterials · 2026
  • K260530epi-ConneKt™ Wound MatrixMLM Biologics, Inc. · 2026
  • K260652ColActive PlusCovalon Technologies, Ltd. · 2026
  • K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus…Berkeley Advanced Biomaterials · 2026
  • K260596Collagen Wound PowderVentris Medical · 2026

https://510kreport.com/device/K040314 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040314: Healicoll.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040314

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026